AB0270 DESIGN OF A PROSPECTIVE MULTI-NATIONAL CROSS-SECTIONAL STUDY ON SCREENING FOR INTERSTITIAL LUNG DISEASE (ILD) IN PATIENTS WITH RHEUMATOID ARTHRITIS (RA) GUIDED BY RISK FACTORS
Authors: J. Sparks, P. Dieudé, A. M. Hoffmann-Vold, G. R. Burmester, S. Walsh, M. Kreuter, C. Stock, S. Sambevski, M. Alves, P. Emery
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> ILD is a significant complication of RA, but diagnosis of RA-ILD is often delayed as respiratory symptoms do not develop until the disease is advanced. Several risk factors for the development of ILD in patients with RA have been identified. Screening tools are required to facilitate earlier detection of RA-ILD in clinical practice. <h3>Objectives</h3> The aim of this prospective cross-sectional study is to develop and validate a multivariable prediction model for RA-ILD screening based on risk factors. <h3>Methods</h3> Investigators will enrol consecutive patients diagnosed with RA who have ≥2 of the following risk factors for ILD: male; current or previous smoker; age ≥60 years at RA onset; high-positive rheumatoid factor and/or anti-cyclic citrullinated peptide (titre &gt;3 x upper limit of normal); high RA disease activity score (based on DAS-28, SDAI, CDAI, RAPID-3, PAS, or PAS-II) ≤12 months prior to screening; presence or history of extra-articular manifestations of RA (vasculitis, Felty's syndrome, secondary Sjögren's syndrome, cutaneous rheumatoid nodules, serositis, and/or scleritis/uveitis). Patients previously identified as having ILD, or who have had a high-resolution computed tomography (HRCT) scan in the prior 2 years, will not be eligible. Patients will undergo an HRCT scan, which will be assessed centrally by two thoracic radiologists. Data will be collected on demographic and RA-related characteristics, patient-reported outcomes, comorbidities and pulmonary function. It is planned that up to 1200 patients will be enrolled at approximately 30 sites in the USA, UK, Germany, France, Italy, Spain. <h3>Results</h3> The results of this study will elucidate the prevalence of RA-ILD, and of features of RA-ILD on HRCT, in the study population and enable development of a probability score for RA-ILD based on a multivariable model incorporating risk factors. The performance, area under the receiver operating characteristic (ROC) curve, sensitivity, specificity and predictive value of the model for predicting the presence of RA-ILD on HRCT (yes/no) will be reported. <h3>Conclusion</h3> The results of this prospective multi-national cross-sectional study will enable development of a screening tool for RA-ILD, guided by risk factors, to identify patients with RA who should be screened for ILD using HRCT. <h3>Acknowledgements</h3> This study is supported by Boehringer Ingelheim International GmbH (BI) <h3>Disclosure of Interests</h3> Jeffrey Sparks Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Inova Diagnostics, Janssen, Optum, and Pfizer, Grant/research support from: Bristol-Myers Squibb, Philippe Dieudé Speakers bureau: AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Galapagos, Janssen, Pfizer, Consultant of: AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Galapagos, Janssen, Novartis, Pfizer, Grant/research support from: Paid to institution from Bristol-Myers Squibb, Chugai, Galapagos, Pfizer, Anna-Maria Hoffmann-Vold Speakers bureau: Boehringer Ingelheim, Janssen, Medscape, Merck Sharp &amp; Dohme, Roche, Consultant of: Arxx Therapeutics, Boehringer Ingelheim, Genentech, Janssen, Medscape, Merck Sharp &amp; Dohme, Roche, Grant/research support from: Boehringer Ingelheim, Janssen, Gerd Rüdiger Burmester Speakers bureau: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Chugai, Galapagos, Lilly, Pfizer, Sanofi., Consultant of: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Galapagos, Lilly, Pfizer, Sanofi., Simon Walsh Speakers bureau: Boehringer Ingelheim, Roche, Galapagos, Paid instructor for: Boehringer Ingelheim, Roche, Consultant of: Boehringer Ingelheim, Roche, Galapagos, Sanofi-Genzyme, OncoArendi Therapeutics, PureTech, Grant/research support from: Boehringer Ingelheim, Galapagos, Michael Kreuter Speakers bureau: Boehringer Ingelheim, Consultant of: Boehringer Ingelheim, Grant/research support from: Boehringer Ingelheim, Christian Stock Employee of: Employee of Boehringer Ingelheim, Steven Sambevski Employee of: Employee of Boehringer Ingelheim, Margarida Alves Employee of: Employee of Boehringer Ingelheim, Paul Emery Consultant of: AbbVie, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Roche, Samsung, Grant/research support from: AbbVie, Bristol-Myers Squibb, Lilly, Novartis, Pfizer, Roche, Samsung.